MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-C ANESTHESIA SYSTEM; GAS-MACHINE, ANESTHESIA

Model Number	6887700
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the system checkout failed and that liquid had entered the air gas module.There was no patient involvement.Manufacturer's reference number: (b)(4).
Event or Problem Description
Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
Our investigation of this complaint has been completed.The anesthesia system was investigated by our field service engineer.The investigation revealed that the system checkout failed during multiple sub tests such as inspiratory and expiratory valves tests.Pressure transducers, vaporizer inlet/outlet valve, flow transducer, and man ventilation leakage.The investigation found liquid that had previously entered the air gas module.The system has not been repaired; the customer has not purchased the parts needed for repair.The received logs confirm the reported issue with several sub test failures during system checkout.All failing tests indicate that the air gas module was not delivering the expected flow.The gas module regulates the inspiratory gas flow and gas mixture.The faulty air gas module may lead to that the amount of oxygen in the gas mixture deviate from the expected, flow and pressure may also deviate.Our conclusion is that the system checkout failures were caused by a faulty air gas module.According to the applicable user's manual, maximum levels of water (h2o < 7 g/m3) in the supplied gases to the anesthesia system must not be exceeded.

• Brand Name: FLOW-C ANESTHESIA SYSTEM
• Common Device Name: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer (Section G): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer Contact: caroline kabbabe ; roentgenvagen 2; solna
• MDR Report Key: 24128896
• Report Number: 8010042-2026-0000061
• Device Sequence Number: 10387502
• Product Code: BSZ
• UDI-Device Identifier: 07325710009765
• UDI-Public: (01)07325710009765(11)200721
• Combination Product (Y/N): N
• Initial Reporter Country: TX
• PMA/510(K) Number: K191027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6887700
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown